MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE S 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3561
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time there is no further information available to report.If additional relevant information is obtained, a supplemental report will be submitted.
Event or Problem Description
It was reported that the insulation of a cryoablation needle failed during a procedure.The icesphere needle passed integrity testing without issue; however, three minutes into the first freeze cycle frost developed on the needle shaft.The physician used sterile warming bags and saline to protect the patient's skin until the needle was passively thawed.The device was removed and replaced with a new icesphere needle.No patient complications were encountered and the treatment was completed successfully without injury.
Event or Problem Description
It was reported that the insulation of a cryoablation needle failed during a procedure.The icesphere needle passed integrity testing without issue; however, three minutes into the first freeze cycle frost developed on the needle shaft.The physician used sterile warming bags and saline to protect the patient's skin until the needle was passively thawed.The device was removed and replaced with a new icesphere needle.No patient complications were encountered and the treatment was completed successfully without injury.
Additional Manufacturer Narrative
The icesphere needle was returned for technical analysis.Engineering testing showed insufficient thermal insulation of the vacuum sleeve, resulting in frost on the shaft.Ice formed on the entire shaft length, therefore the ice ball margins could not be determined.Disassembly of the device revealed no soldering flux residuals or corrosive signs on the external surface of the vacuum sleeve, and no gas leaks were detected.No relationship between the needle's assembly processes and the vacuum loss phenomena was identified.

• Brand Name: ICESPHERE S 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10744654
• Report Number: 2134265-2020-14814
• Device Sequence Number: 3141320
• Product Code: GEH
• UDI-Device Identifier: 07290104830556
• UDI-Public: 07290104830556
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2021
• Device Model Number: FPRPR3561
• Device Catalogue Number: FPRPR3561
• Device Lot Number: T0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/04/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1